Eyelashes May Benefit from Glaucoma Drug (Update)

UPDATE: Latisse, a cosmetic treatment to enhance lashes, has received FDA approval, according to its manufacturer, Allergan, Inc. The product, a spinoff of glaucoma drug Lumigan, will be available in the first quarter of 2009.

Looking at people’s eyes is a normal part of communication. Often called "the windows of the soul," our eyes can not only reflect our innermost thoughts, they can send many different non-verbal signals to others; signals of anger, fear, happiness, compassion and lust. Perhaps that’s why the appearance of the eye is so important to so many, evident by the millions of dollars Americans spend each year on products developed specifically for the care and decoration of our eyes. There are creams that help eliminate puffy eyes, undereye circles and wrinkles, tinted lenses to enhance or change the color of the eye, and countless brands and types of eye makeup, including liners, shadows, and the quintessential, mascara. First created by Maybelline, mascara as we know it is a far cry from the kohl (soot) used in ancient times, but there may soon be another option for obtaining longer, thicker, and darker lashes—from a surprising source.

When a drug called Lumigan was being tested for use in patients with glaucoma, it was found to have an unusual side effect; it increased the length of eyelashes. The drug maker, Allergan Inc., is now seeking federal approval to market a spin-off of the drug—Latisse—as a cosmetic treatment to those wanting longer, thicker, darker lashes. However, if approved, instead of going directly on the eyes as Lumigan does, Latisse will be packaged with a special applicator to apply the drops at the roots of the eyelashes, and each Latisse dose uses only 5 percent of a Lumigan drop.

In a study to evaluate the eyelash use, 137 people used Latisse and 141 others used a placebo solution for 16 weeks. The appearance of eyelashes was rated on a four-point scale ranging from "minimal" to "very marked." By the end of the study, 78 percent of the Latisse group had at least a one-point improvement, compared with 18 percent of the placebo group. Those in the Latisse group also reported more satisfaction with their lashes as did the people who received the placebo. Side effects, which included eye redness, were generally temporary and mild and stopped when the drug was discontinued. On the downside, a person using Latisse for eyelash growth must continue to apply it or their eyelashes will shrink back to their previous length within a few months.

An FDA advisory panel voted unanimously that the drug’s benefits outweigh its risks. “I have absolutely no reason to question the efficacy or the effect of Lumigan,” said Dr. M. Roy Wilson, chancellor of the University of Denver. “I also want to emphasize that I don’t have any concerns about potential side effects on the eyelid.” The same panel, however, voted 5-3 with one abstention that Allergen Inc. should be required to conduct follow-up studies to address questions about use of the drug among certain patients, such as young patients, the African-American population and people who lost their lashes because of chemotherapy.

The panel also discussed what types of physicians should be able to prescribe the drug. While the drugmaker would like any licensed physician to be able to write a prescription, panelists debated whether younger patients should be able to obtain the drug after seeing only an eye specialist. “I’m worried about off-label, non-supervised use of this medication, and I’m concerned teenagers might use it three or four times a day instead of once,” said Dr. Marijean Miller, an ophthalmologist with the Children’s National Medical Center in Washington.

Consumer advocates voiced another concern: the drug may cause light-colored eyes to gradually turn brown if too much gets into the eye, a side effect seen with Lumigan. “Changing eye color is an adverse reaction that is acceptable to someone trying to prevent blindness from glaucoma, but is probably not acceptable to someone using the product to improve their eyelashes,” said Brandel France deBravo, a spokeswoman for the National Research Center for Women and Families. But Allergan officials said most patients did not notice the color change and most side effects were completely reversible when patients stopped using the drops. 

The FDA is not required to follow the recommendations of its advisory panels, although it normally does. Allergan anticipates launching Latisse in 2009, according to a company news release. “Latisse will offer consumers an FDA-approved product which has been extensively studied and is regulated as a prescription product,” said Scott Whitcup, Allergan’s executive vice president of research and development.